Dolutegravir sodium - Generic Drug Details

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What are the generic drug sources for dolutegravir sodium and what is the scope of freedom to operate?

Dolutegravir sodium is the generic ingredient in four branded drugs marketed by Viiv Hlthcare and is included in four NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium has one hundred and fifty-five patent family members in thirty-five countries.

There are seventeen drug master file entries for dolutegravir sodium. Three suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for dolutegravir sodium

International Patents:	155
US Patents:	6
Tradenames:	4
Applicants:	1
NDAs:	4
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	1
Patent Applications:	96
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dolutegravir sodium
What excipients (inactive ingredients) are in dolutegravir sodium?	dolutegravir sodium excipients list
DailyMed Link:	dolutegravir sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dolutegravir sodium

Generic Entry Dates for dolutegravir sodium^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET, FOR SUSPENSION;ORAL
Generic Entry Dates for dolutegravir sodium^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for dolutegravir sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
St Stephens Aids Trust	Phase 4

See all dolutegravir sodium clinical trials

Generic filers with tentative approvals for DOLUTEGRAVIR SODIUM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	50MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	50MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	50MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dolutegravir sodium

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dolutegravir sodium

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIVICAY PD	Tablets for Suspension	dolutegravir sodium	5 mg	213983	1	2021-07-21
TIVICAY	Tablets	dolutegravir sodium	10 mg, 25 mg and 50 mg	204790	4	2017-08-14

US Patents and Regulatory Information for dolutegravir sodium

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	Jun 9, 2016		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-002	Jun 9, 2016		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for dolutegravir sodium

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Country	Patent Number	Title	Estimated Expiration
Slovenia	3284520		⤷ Sign Up
Lithuania	3372281		⤷ Sign Up
Israel	225207	נגזרת של קרבאמוילפירידון רב-טבעתי, הרכב רוקחי המכיל אותה, השימוש בה ותהליך להכנתה (Polycyclic carbamoylpyridone derivative, pharmaceutical composition comprising the same, use and process for preparation thereof)	⤷ Sign Up
European Patent Office	3372281	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)	⤷ Sign Up
Cyprus	1116331		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for dolutegravir sodium

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3494972	PA2024516	Lithuania	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA DRUSKA, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA IR LAMIVUDINA; REGISTRATION NO/DATE: EU/1/19/1370 20190701
3494972	LUC00346	Luxembourg	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
1874117	C 2014 024	Romania	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
3494972	122024000031	Germany	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM, MIT LAMIVUDIN; REGISTRATION NO/DATE: EU/1/19/1370 20190701
1874117	14C0041	France	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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